Lactobacillus Reuteri Strain Combination in Children Treated With PPI

Launched by UNIVERSITY OF BARI · Jul 29, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a combination of two special probiotic strains called Lactobacillus Reuteri in children who are being treated with Proton Pump Inhibitors (PPIs) for conditions like gastroesophageal reflux disease (GERD) or functional dyspepsia. Probiotics are beneficial bacteria that may help maintain a healthy balance of gut bacteria and prevent issues such as dysbiosis (an imbalance of gut bacteria) and small intestinal bacterial overgrowth (SIBO). The specific probiotic mixture being tested is thought to not only help with stomach health but also reduce inflammation.

To participate in this trial, children aged between 1 month and 14 years old who are using PPIs for their condition may be eligible, but the study will begin with those older than 4 years. However, certain conditions would exclude a child from participating, such as having neurological disorders, feeding through a tube, or known immune system issues. Families who choose to participate can expect to be involved in a study aimed at improving the health of children experiencing stomach issues while undergoing PPI treatment. The trial is currently recruiting participants, so it’s an opportunity to contribute to important research that could benefit many children in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age: children between 1 month and 14 years of age;
• • o We start with children older than 4 years of age.
• • Necessity of therapy with Proton Pump Inhibitors for Gastroesophageal reflux disease and/or Functional Dyspepsia;
• • Informed consent obtained.
• Exclusion Criteria:
• • Neurological pathologies (PCI and Spastic tetra-paresis);
• • Nasogastric feeding;
• • Known immunodeficiency;
• • Previous therapy with gastric acid inhibitors;
• • HP infection;
• • Assumption of prebiotics, other probiotics or symbiotics in the previous month;
• • Malnutrition or severe dystrophy;
• • Cystic Fibrosis.